A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries

NCT ID: NCT00349908

Last Updated: 2014-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-03-31

Brief Summary

Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.

Detailed Description

Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries. Patients will be followed for 6 months with assessments related to technical feasibility and adverse events.

Conditions

Atherosclerosis; Aneurysm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Atherosclerosis Arm

Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Group Type: EXPERIMENTAL

Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Intervention Type: DEVICE

Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.

Group 2: Aneurysm Arm

Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Group Type: ACTIVE_COMPARATOR

Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Intervention Type: DEVICE

Implantation of the device ENTERPRISE to treat wide-necked aneurysms

Interventions

Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.

Intervention Type: DEVICE

Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Implantation of the device ENTERPRISE to treat wide-necked aneurysms

Intervention Type: DEVICE

Other Intervention Names

Other Names: ENTERPRISE Vascular Reconstruction Device (VRD); ENTERPRISE VRD; ENTERPRISE; ENTERPRISE Vascular Reconstruction Device (VRD); ENTERPRISE VRD; ENTERPRISE

Eligibility Criteria

Inclusion Criteria

• Subject meet specific criteria for treatment
• Subject must be willing to return to site for 30 day and 6 month follow up evaluations

Exclusion Criteria

• Stenting, angioplasty or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
• Previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Codman & Shurtleff

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Lylyk, MD

Role: PRINCIPAL_INVESTIGATOR

ENERI-CLINICA ADVENTISTA BELGRANO

Locations

Eneri-Clinica Adventista Belgrano

Belgrano, , Argentina

Countries

Argentina

Other Identifiers

CNV:ARG:P-01

Identifier Type: -

Identifier Source: org_study_id